Clinical Efficacy of Preformed Pediatric Zirconia and Metal Crown

• Sponsor: Marmara University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05910905
• Collaborator: (none)
• Enrollment: 50
• Arms: 2
• Anticipated Duration (Months): 20

Study Details

Study Description

Brief Summary

The study was planned to evaluate and compare the clinical success of prefabricated stainless steel crowns and zirconia crowns used in the primary molars.

The study will be carried out in healthy children aged 6-9 years with caries on more than one surface of the primary molars.

Condition or Disease	Intervention/Treatment	Phase
Carious Teeth	Procedure: Prefabricated pediatric zirconia crown group; Procedure: Prefabricated stainless steel crown group	N/A

Detailed Description

In this study, zirconia crowns will be compared with prefabricated stainless steel crowns in a randomized controlled manner. The study will be conducted in split-mouth to eliminate the effect of potential confounders. The obtained data will be analyzed using appropriate statistical methods.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of Clinical Efficacy of Preformed Pediatric Zirconia Crown and Preformed Pediatric Metal Crown: A Randomized Clinical Study
• Anticipated Study Start Date: Jul 1, 2023
• Anticipated Primary Completion Date: May 1, 2024
• Anticipated Study Completion Date: Mar 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Prefabricated pediatric zirconia crown group Zirconia crowns (ZK; EZ Crowns, Spring Oral Health Technologies, Inc:, Loomis, Calif., USA).	Procedure: Prefabricated pediatric zirconia crown group; Zirconia crown application: After preparing the molars, the crown was cemented by passive seating with modified glass ionomer cement (GC FujiCEM Evolve, GC America, Alsip, USA).
Active Comparator: Prefabricated stainless steel crown group Stainless Steel Crown (SSC, Kids Crown, Shinghung, Seoul, Korea)	Procedure: Prefabricated stainless steel crown group; Stainless steel crown application: After preparing the molars, the crown was filled with type-1 glass ionomer cement (Aqua Meron, Voco, Cuxhaven, Germany) and cemented.

Outcome Measures

Primary Outcome Measures

1. Comparison of clinical success [24 month]

   According to the criteria reported by Santamaria et al. (2004), clinical success will be categorized as successful, major failure, and minor failure. Successful: No clinical signs or symptoms of pulp pathology Tooth has exfoliated (without any minor/major failures) No deformations in the crown/restoration No pathology observed in radiographs Minor failure: Reversible pulpitis (No need for root canal treatment or extraction) Crown/restoration loss that can be restored Presence of deformations/fractures/perforations in the crown/restoration Permanent crown remaining submerged Presence of new caries at the margins Major failure: Irreversible pulpitis Crown/restoration loss that cannot be restored Inter-radicular radiolucency Internal root resorption

Secondary Outcome Measures

1. Parental satisfaction [24 month]

   To assess parental satisfaction regarding the applied restorations, scoring of crowns' appearance, color, shape, size, and general appearance will be requested using a Likert-type scale (Suguna & Gurunathan, 2021). Score 5 indicates the highest level of satisfaction, while score 1 represents the lowest level of satisfaction. Not at all satisfied Not satisfied Neither satisfied nor dissatisfied (Neutral) Satisfied Very satisfied

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 9 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy children aged 6-9 years with caries on primary molars

• Children without systemic disease or developmental dental anomalies that may affect caries susceptibility.

• Children whose cooperation is 'positive' or 'absolutely positive' according to the Frankl behavioral scale (Frankl et al., 1962).

• Those with deep dentin caries that do not extend to the pulp in the teeth to be treated

• The molars will be treated with a crown indication.

• Presence of symmetry of the primary molar to be treated in the opposite arch.

• The molar to be treated is in occlusion with the antagonist.

• Presence of caries on at least two surfaces of the molars to be treated.

• Absence of spontaneous pain, abscess, mobility, interradicular lesion in the tooth to be treated

• Patients whose parents and themselves agree to participate in the treatment

Exclusion Criteria:

• Children whose treatment cannot be continued on the dental chair due to cooperation

• Molars that will soon be exfoliated, 1/2 of the root has been resorbed

• The presence of bruxism

• The presence of erosion or attrition-related wear on the opposing molar

• The patient does not come to the control appointment or does not want to continue to the research

• Have allergy to local anesthetic, nickel or chromium

• Complications during treatment.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Marmara University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Haner Direskeneli, Professor, Marmara University
• ClinicalTrials.gov Identifier: NCT05910905
• Other Study ID Numbers: 17.05.23marmara
• First Posted: Jun 20, 2023
• Last Update Posted: Jun 20, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dental Caries

Study Results

No Results Posted as of Jun 20, 2023